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NCT07144826 · ClinicalTrials.gov registry record · Early Phase 1
Effects of a Probiotic Intervention on the Gut and Vaginal Microbiome in Patients With Advanced or Recurrent Ovarian Cancer Undergoing Treatment With Platinum Chemotherapy
A Early Phase 1 study of Recurrent Ovarian Carcinoma and Advanced Ovarian Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 161
- Enrollment target
- 1
- Study location
NCT07144826: Recruiting Early Phase 1 study of Recurrent Ovarian Carcinoma and Advanced Ovarian Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center.
NCT07144826 is a Early Phase 1 study of Recurrent Ovarian Carcinoma and Advanced Ovarian Carcinoma that is actively recruiting participants, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 161 participants, above the 120-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (34% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07144826, a Early Phase 1 study of Recurrent Ovarian Carcinoma and Advanced Ovarian Carcinoma, is actively recruiting participants, sponsored by Ohio State University Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 161 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical trial evaluates the effects a probiotic intervention has on the gut and vaginal microbiome in patients undergoing chemotherapy for ovarian cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has come back after a period of improvement (recurrent). Gut health is also known as the gut microbiome. The microbiome includes all of the bacteria and organisms naturally found in the digestive tract. Probiotics are dietary supplements containing live microorganisms that may help keep the gastrointestinal tract healthy. A probiotic intervention during platinum chemotherapy in ovarian cancer patients may impact the gut and vaginal microbiota, quality of life, symptoms, and oncologic outcomes.
Primary Outcome
Will be assessed by stool samples collected from all patients. Microbe diversity and communities are assessed by 16s ribosomal ribonucleic acid sequencing and metagenomic whole-genome shotgun sequencing. Presence of microbes between responders and non-responders will be compared using Fisher's exact tests and logistic regression. Changes over time will be assessed using generalized linear or logistic regression models accounting for repeated measures, depending on the format of the outcome varia
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
- DIETARY_SUPPLEMENT Probiotic
- DRUG Placebo Administration
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2026-03-09 |
| Est. Completion | 2027-07-09 |
| Phase | Early Phase 1 |
What NCT07144826 shows while recruiting
NCT07144826 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, above the 120-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (34% higher).
The record links to 5 conditions, with Recurrent Ovarian Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT07144826 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT07144826 about?
NCT07144826 is a clinical study titled "Effects of a Probiotic Intervention on the Gut and Vaginal Microbiome in Patients With Advanced or Recurrent Ovarian Cancer Undergoing Treatment With Platinum Chemotherapy". This clinical trial evaluates the effects a probiotic intervention has on the gut and vaginal microbiome in patients undergoing chemotherapy for ovarian cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has come bac...
What is the current status of trial NCT07144826?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 161 participants. The study started on 2026-03-09. Estimated completion is 2027-07-09.
What conditions does trial NCT07144826 study?
This clinical trial studies the following conditions: Recurrent Ovarian Carcinoma, Advanced Ovarian Carcinoma, Stage III Ovarian Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage II Ovarian Cancer AJCC v8.
What interventions are being tested in trial NCT07144826?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Probiotic (DIETARY_SUPPLEMENT), Placebo Administration (DRUG).
Who is sponsoring clinical trial NCT07144826?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07144826 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Ovarian Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07144826's enrollment target sits among peer trials
161 5th of 39 higher than 35 of 39 other Recurrent Ovarian Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Ovarian Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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